Metformin hydrochloride
- Product NDC
- 68682-021
- 11-digit product format
- 686820021
- Labeler code
- 68682
- Product ID
- 68682-021_26e1cf7e-cc48-cc39-e063-6394a90a62cc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- metformin hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Oceanside Pharmaceuticals
- Application
- NDA021748
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2018-03-20
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Metformin hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METFORMIN HYDROCHLORIDE | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 1807888, 1807915 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68682-021-50 | Metformin hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68682-021 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS] | 10 | Current NDC, Legacy NDC, 1 package rows | 20241116_74d32a8a-c4c2-4dbb-b376-eea3f8fa64d7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68682-021-50 | 68682002150 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68682-021-50) | 2018-03-20 | 0000-00-00 | No | No | Current |